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CompletedNCT03800797Updated Jan 11, 2019

Efficacy and Safety of Loxoprofen Hydrogel Patch in Patients With Ankylosing Spondylitis

A Phase 4 interventional study of Loxoprofen sodium hydrogel patch and Loxoprofen sodium tablet in Ankylosing Spondylitis, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-01-11.

Sponsored by Sun Yat-sen University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 7 months after the study started (first participant enrolled May 2015, registered Jan 2019).
Phase
Phase 4
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

To assess the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) versus loxoprofen sodium tablet (LX-T) in patients with active ankylosing spondylitis(AS). The trial includes 70 patients who are randomly assigned to either the LX-P group (LX-P 100 mg per day) or LX-T group (LX-T 60 mg t.i.d.) for 4 weeks.

Read the detailed description

This is a 4-week randomized, open-label trial to investigate the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) versus loxoprofen sodium tablet (LX-T) in patients with active ankylosing spondylitis(AS). The trial includes 70 patients who are randomly assigned to either the LX-P group (LX-P 100 mg per day) or LX-T group (LX-T 60 mg t.i.d.) for 4 weeks.

02

Conditions studied

  • Ankylosing Spondylitis

Keywords

  • ankylosing spondylitis
  • loxoprofen
  • patch
03

In context

Spondylitis, Ankylosing

507 studies on the registry are indexed under Spondylitis, Ankylosing; 91 are open to participants now.

This study's enrollment of 70 is below the median of 84 across 281 interventional studies indexed under Spondylitis, Ankylosing.

Browse Spondylitis, Ankylosing studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,680 studies on the registry; 609 are open to participants now.

Browse Sun Yat-sen University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 to 65 years
  • Meet 1984 modified New York criteria for AS
  • The Bath AS Disease Activity Index (BASDAI) ≥4 on a 0-10-cm visual analog scale or the Ankylosing Spondylitis Disease Activity Score using the C-reactive protein level (ASDAS-CRP) ≥1.3
  • NSAIDs washout period of at least 5 days prior to randomization
  • DMARDs washout period of at least 4 weeks prior to randomization
  • Corticosteroids washout period of at least 4 weeks prior to randomization
  • Biological agents washout period of at least 3 months prior to randomization.

Exclusion criteria

Exclusion Criteria:

  • Peptic ulcer
  • Unstable cardiac diseases
  • Abnormal hepatic function with an elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 times of upper normal limits
  • Abnormal renal function with creatinine more than upper normal limit
  • Hematologic disorders
  • Psychosis
  • Malignancy
  • Allergic to LX drug.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    LX-P group

    loxoprofen sodium hydrogel patch (LX-P) 100 mg per day for 4 weeks

    Drug: Loxoprofen sodium hydrogel patch

  • Active comparator
    LX-T group

    loxoprofen sodium tablet (LX-T) 60 mg t.i.d. for 4 weeks

    Drug: Loxoprofen sodium tablet

Interventions

  • DrugLoxoprofen sodium hydrogel patch

    100 mg per day

    Also known as: Loxoprofen hydrogel patch

  • DrugLoxoprofen sodium tablet

    60 mg t.i.d.

    Also known as: Loxoprofen tablet

06

What researchers measure

Primary outcomes

  1. the proportions of patients reaching Assessment in Ankylosing Spondylitis 20% response (ASAS20)

    ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥1 unit (0-10-cm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (mean of total and nocturnal pain scores), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)

    Time frame: week 4

Secondary outcomes

  1. ASAS5/6 response

    defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP)

    Time frame: week 4

  2. ASAS20 response

    ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥1 unit (0-10-cm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (mean of total and nocturnal pain scores), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)

    Time frame: week 2

  3. ASAS5/6 response

    defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP)

    Time frame: week 2

07

Study locations

1 site
  • Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2015 to primary completion in Dec 2015, 6 months.

Of 18 phase 4 interventional studies under Spondylitis, Ankylosing, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 36. This study's 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 7, 2019
First posted
Jan 11, 2019
StartActual
May 25, 2015
Primary completionActual
Dec 10, 2015
CompletionActual
Dec 10, 2015
Last update
Jan 11, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03800797
Lead sponsor
Sun Yat-sen University
Responsible party
Gu Jieruo (Director, Department of Rheumatology, The Third Affiliated Hospital of Sun Yat-Sen University, Sun Yat-sen University) — Principal investigator
First posted
Jan 11, 2019
Start date
May 25, 2015
Primary completion
Dec 10, 2015
Completion
Dec 10, 2015
Last update
Jan 11, 2019

Study contacts

Jieruo Gu, Prof
study director · Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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